Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer

An Eastern Cooperative Oncology Group trial

Patrick Loehrer, Yang Feng, Higinia Cardenes, Lynne Wagner, Joanna M. Brell, David Cella, Patrick Flynn, Ramesh K. Ramanathan, Christopher H. Crane, Steven R. Alberts, Al B. Benson

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Abstract

Purpose: The purpose of this trial was to evaluate the role of radiation therapy with concurrent gemcitabine (GEM) compared with GEM alone in patients with localized unresectable pancreatic cancer. Patients and Methods: Patients with localized unresectable adenocarcinoma of the pancreas were randomly assigned to receive GEM alone (at 1,000 mg/m 2/wk for weeks 1 to 6, followed by 1 week rest, then for 3 of 4 weeks) or GEM (600 mg/m 2/wk for weeks 1 to 5, then 4 weeks later 1,000 mg/m 2 for 3 of 4 weeks) plus radiotherapy (starting on day 1, 1.8 Gy/Fx for total of 50.4 Gy). Measurement of quality of life using the Functional Assessment of Cancer Therapy-Hepatobiliary questionnaire was also performed. Results: Of 74 patients entered on trial and randomly assigned to receive GEM alone (arm A; n = 37) or GEM plus radiation (arm B; n = 34), patients in arm B had greater incidence of grades 4 and 5 toxicities (41% v 9%), but grades 3 and 4 toxicities combined were similar (77% in A v 79% in B). No statistical differences were seen in quality of life measurements at 6, 15 to 16, and 36 weeks. The primary end point was survival, which was 9.2 months (95% CI, 7.9 to 11.4 months) and 11.1 months (95% CI, 7.6 to 15.5 months) for arms A and B, respectively (one-sided P = .017 by stratified log-rank test). Conclusion: This trial demonstrates improved overall survival with the addition of radiation therapy to GEM in patients with localized unresectable pancreatic cancer, with acceptable toxicity.

Original languageEnglish
Pages (from-to)4105-4112
Number of pages8
JournalJournal of Clinical Oncology
Volume29
Issue number31
DOIs
StatePublished - Nov 1 2011

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gemcitabine
Pancreatic Neoplasms
Radiotherapy
Quality of Life
Survival
Pancreas
Adenocarcinoma

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer : An Eastern Cooperative Oncology Group trial. / Loehrer, Patrick; Feng, Yang; Cardenes, Higinia; Wagner, Lynne; Brell, Joanna M.; Cella, David; Flynn, Patrick; Ramanathan, Ramesh K.; Crane, Christopher H.; Alberts, Steven R.; Benson, Al B.

In: Journal of Clinical Oncology, Vol. 29, No. 31, 01.11.2011, p. 4105-4112.

Research output: Contribution to journalArticle

Loehrer, P, Feng, Y, Cardenes, H, Wagner, L, Brell, JM, Cella, D, Flynn, P, Ramanathan, RK, Crane, CH, Alberts, SR & Benson, AB 2011, 'Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer: An Eastern Cooperative Oncology Group trial', Journal of Clinical Oncology, vol. 29, no. 31, pp. 4105-4112. https://doi.org/10.1200/JCO.2011.34.8904
Loehrer, Patrick ; Feng, Yang ; Cardenes, Higinia ; Wagner, Lynne ; Brell, Joanna M. ; Cella, David ; Flynn, Patrick ; Ramanathan, Ramesh K. ; Crane, Christopher H. ; Alberts, Steven R. ; Benson, Al B. / Gemcitabine alone versus gemcitabine plus radiotherapy in patients with locally advanced pancreatic cancer : An Eastern Cooperative Oncology Group trial. In: Journal of Clinical Oncology. 2011 ; Vol. 29, No. 31. pp. 4105-4112.
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abstract = "Purpose: The purpose of this trial was to evaluate the role of radiation therapy with concurrent gemcitabine (GEM) compared with GEM alone in patients with localized unresectable pancreatic cancer. Patients and Methods: Patients with localized unresectable adenocarcinoma of the pancreas were randomly assigned to receive GEM alone (at 1,000 mg/m 2/wk for weeks 1 to 6, followed by 1 week rest, then for 3 of 4 weeks) or GEM (600 mg/m 2/wk for weeks 1 to 5, then 4 weeks later 1,000 mg/m 2 for 3 of 4 weeks) plus radiotherapy (starting on day 1, 1.8 Gy/Fx for total of 50.4 Gy). Measurement of quality of life using the Functional Assessment of Cancer Therapy-Hepatobiliary questionnaire was also performed. Results: Of 74 patients entered on trial and randomly assigned to receive GEM alone (arm A; n = 37) or GEM plus radiation (arm B; n = 34), patients in arm B had greater incidence of grades 4 and 5 toxicities (41{\%} v 9{\%}), but grades 3 and 4 toxicities combined were similar (77{\%} in A v 79{\%} in B). No statistical differences were seen in quality of life measurements at 6, 15 to 16, and 36 weeks. The primary end point was survival, which was 9.2 months (95{\%} CI, 7.9 to 11.4 months) and 11.1 months (95{\%} CI, 7.6 to 15.5 months) for arms A and B, respectively (one-sided P = .017 by stratified log-rank test). Conclusion: This trial demonstrates improved overall survival with the addition of radiation therapy to GEM in patients with localized unresectable pancreatic cancer, with acceptable toxicity.",
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AU - Wagner, Lynne

AU - Brell, Joanna M.

AU - Cella, David

AU - Flynn, Patrick

AU - Ramanathan, Ramesh K.

AU - Crane, Christopher H.

AU - Alberts, Steven R.

AU - Benson, Al B.

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N2 - Purpose: The purpose of this trial was to evaluate the role of radiation therapy with concurrent gemcitabine (GEM) compared with GEM alone in patients with localized unresectable pancreatic cancer. Patients and Methods: Patients with localized unresectable adenocarcinoma of the pancreas were randomly assigned to receive GEM alone (at 1,000 mg/m 2/wk for weeks 1 to 6, followed by 1 week rest, then for 3 of 4 weeks) or GEM (600 mg/m 2/wk for weeks 1 to 5, then 4 weeks later 1,000 mg/m 2 for 3 of 4 weeks) plus radiotherapy (starting on day 1, 1.8 Gy/Fx for total of 50.4 Gy). Measurement of quality of life using the Functional Assessment of Cancer Therapy-Hepatobiliary questionnaire was also performed. Results: Of 74 patients entered on trial and randomly assigned to receive GEM alone (arm A; n = 37) or GEM plus radiation (arm B; n = 34), patients in arm B had greater incidence of grades 4 and 5 toxicities (41% v 9%), but grades 3 and 4 toxicities combined were similar (77% in A v 79% in B). No statistical differences were seen in quality of life measurements at 6, 15 to 16, and 36 weeks. The primary end point was survival, which was 9.2 months (95% CI, 7.9 to 11.4 months) and 11.1 months (95% CI, 7.6 to 15.5 months) for arms A and B, respectively (one-sided P = .017 by stratified log-rank test). Conclusion: This trial demonstrates improved overall survival with the addition of radiation therapy to GEM in patients with localized unresectable pancreatic cancer, with acceptable toxicity.

AB - Purpose: The purpose of this trial was to evaluate the role of radiation therapy with concurrent gemcitabine (GEM) compared with GEM alone in patients with localized unresectable pancreatic cancer. Patients and Methods: Patients with localized unresectable adenocarcinoma of the pancreas were randomly assigned to receive GEM alone (at 1,000 mg/m 2/wk for weeks 1 to 6, followed by 1 week rest, then for 3 of 4 weeks) or GEM (600 mg/m 2/wk for weeks 1 to 5, then 4 weeks later 1,000 mg/m 2 for 3 of 4 weeks) plus radiotherapy (starting on day 1, 1.8 Gy/Fx for total of 50.4 Gy). Measurement of quality of life using the Functional Assessment of Cancer Therapy-Hepatobiliary questionnaire was also performed. Results: Of 74 patients entered on trial and randomly assigned to receive GEM alone (arm A; n = 37) or GEM plus radiation (arm B; n = 34), patients in arm B had greater incidence of grades 4 and 5 toxicities (41% v 9%), but grades 3 and 4 toxicities combined were similar (77% in A v 79% in B). No statistical differences were seen in quality of life measurements at 6, 15 to 16, and 36 weeks. The primary end point was survival, which was 9.2 months (95% CI, 7.9 to 11.4 months) and 11.1 months (95% CI, 7.6 to 15.5 months) for arms A and B, respectively (one-sided P = .017 by stratified log-rank test). Conclusion: This trial demonstrates improved overall survival with the addition of radiation therapy to GEM in patients with localized unresectable pancreatic cancer, with acceptable toxicity.

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